WEST CHESTER, PA — Centinel Spine®, LLC, a Chester County-based medical device company specializing in cervical and lumbar spinal disease solutions, has recently announced that the Food and Drug Administration (FDA) has accepted its Premarket Approval (PMA) application for the Investigational Device Exemption (IDE) study. The study evaluates the Company’s prodisc C Vivo and prodisc C SK cervical total disc replacement (TDR) system. The company’s PMA application was filed on September 27, 2023, and is now undergoing a substantive review by the FDA.
Centinel Spine® is globally recognized for its prodisc® technology platform, which stands as the most studied and clinically proven TDR system worldwide. Validated by over 540 published papers and more than 250,000 implantations across the globe, prodisc® technology continues to be at the forefront of spinal disease treatment.
The recent clinical trial aimed to assess the safety and effectiveness of the prodisc C Vivo and prodisc C SK system. It accomplished this by comparing it with an approved TDR product for 2-level indications. This made it the first-ever IDE trial allowing surgeons to choose from two different TDR devices to individually treat each surgical level.
The trial enrolled 431 subjects at 29 sites across the United States, concluding enrollment in June 2023. A unique aspect of the trial was allowing surgeons to select the investigational device— the prodisc C Vivo and/or prodisc C SK—based on the patient’s anatomy and other surgical factors.
Orthopedic spine surgeon Dr. Brian Perri from DOCS Health in Los Angeles, CA, one of the lead investigators in the study, said, “Centinel Spine is once again working to demonstrate innovation, safety, and effectiveness in their line of cervical disc replacements through this unique study. I hope for FDA approval soon—making Centinel Spine the first company to offer multiple disc designs for two-level procedures and allowing the surgeon to select the best cervical total disc replacement for each level treated.”
Centinel Spine CEO Steve Murray also commented on the trial, stating, “This trial is in line with Centinel Spine’s strategy to be the only company to provide both cervical and lumbar intraoperative prodisc options for one- and two-level total disc replacement procedures. We look forward to the FDA’s diligent review of the PMA submission.”
The prodisc C Vivo system has been in clinical use internationally since 2009. It is currently one of the most frequently implanted TDR devices in the world. The prodisc C SK device features a flat endplate designed for optimized implant positioning that allows surgeons to address individual patient anatomy—with a low-profile central keel that provides immediate fixation and enables a streamlined keel preparation technique.
This milestone in the field of spinal disease treatment not only highlights Centinel Spine’s commitment to innovation but also its dedication to providing more effective solutions for patients and surgeons alike.
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